Coronary Artery DiseaseMAGMARISNCT03413813
Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
An observational study of Coronary Artery Disease, run by Spanish Society of Cardiology at 31 sites in Spain.
Trial summary
The safety and efficacy of percutaneous coronary revascularization has been progressively increasing since its inception, and the problem of restenosis has been minimized. The efficacy and safety data of the Magmaris stent are quite high, in selected cases. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Magmaris
- Type of treatment
- Medical device
- How many people
- 262 participants
- Where
- 31 sitesSpain
- Study dates
- 26 Jul 2017to 7 Jun 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic heart disease by de novo lesions in native coronary arteries, candidates for revascularization with coronary stent.
Who may be able to join
- BASIC CRITERIA:
- Patients who agree to participate in the study, signing the informed consent form.
- The implantation of the bioresorbable MAGMARIS coronary device used according to the indications for use in the center's routine clinical practice.
- Patients of both sexes over 18 years of age.
- The patient does not present any contraindication regarding the taking of dual therapy of antiplatelet therapy with aspirin indefinitely and with thienopyridines for at least the first 6 months.
- CLINICAL CRITERIA:
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- Angor stable or anginal equivalent diagnosis of stable chronic ischemic heart disease.
- Documented silent ischemia
- Acute coronary syndrome (excluding AMI with ST-segment elevation <24 hours)
- Angina Equivalent
- ANGIOGRAPHICAL CRITERIA:
- One or more de novo lesions (stenosis> 70% by visual estimation or> 50% by estimation of quantitative automatic angiography) in native coronary arteries.
- Vessel reference diameter ≥2.7 and ˂3.75.
- Maximum length of the lesion to be treated must be less than the nominal length of the device (15 mm, 20 mm, 25 mm) or capable of being covered with more than one scaffold implanted in an overlapped manner by at least 1 mm with respect to the adjacent.
Who cannot join
- CLINICS:
- Cardiogenic shock
- Acute Myocardial Infarction (first 24 hours).
- Concurrent diseases with life expectancy of less than 1 year
- Women of reproductive age who do not use contraception.
- Women who are pregnant or breast-feeding.
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- Allergies: AAS, Thienopyridines, Magnesium.
- ANATOMICS:
- Main coronary artery lesion
- Lesion in aorto-coronary graft of saphenous vein or mammary artery.
- Intra-stent restenosis lesion.
- Lesion chronic total occlusion.
- Bifurcation lesion
- Severely calcified or severely tortuous coronary artery.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Hospital Universitario Infanta Cristina
Badajoz, 06080
Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903
Hospital del Mar
Barcelona, 08003
Hospital Universitario Vall d´Hebron
Barcelona, 08035
Hospital Universitario Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003
Hospital Universitario Puerta del Mar
Cadiz, 11009
Hospital Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital Universitario General de Castellón
Castellon, Castellón, 12004
Hospital Universitario General de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario Doctor Josep Trueta
Girona, 17007
Hospital San Cecilio-Campus de la Salud
Granada, 18016
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario Puerto Real
Puerto Real, Cádiz, 11510
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital Universitario Clínico de Valencia
Valencia, 46010
Hospital Universitario General de Valencia
Valencia, 46014
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, 36312
Hospital Universitario de Áraba
Vitoria-Gasteiz, Álava, 01009
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
About this study
Official title: Prospective Observational Registry of Patients With a Bioabsorbable Magnesium Stent Implant -MAGMARIS- in Usual Clinical Practice
The safety and efficacy of percutaneous coronary revascularization has been progressively increasing since its inception, and the problem of restenosis has been minimized.
The efficacy and safety data of the Magmaris stent are quite high, in selected cases.
The objective is to evaluate the efficacy and safety of the bioabsorbable stent MAGMARIS in the percutaneous treatment of severe coronary disease (in vessels between 2.7mm and 3.75 mm) in routine clinical practice in poorly selected populations.
Read the detailed description
This is a multicentre, observational, prospective registry of patients without a control group designed to evaluate the efficacy and safety of the bioabsorbable coronary device, according to the indications for use, in routine clinical practice in a consecutive number of patients undergoing percutaneous coronary intervention (PCI) in de novo coronary arteries lesions in a native coronary artery.
After the implantation of the device, a telephone or face-to-face follow-up will be carried out in the first month, at 12 months and at 24 months.
A total of 445 patients are expected to be included in the registry. Patients, will be included consecutively in each center over a year. A selection period of 23 months or until the estimated sample size has been planned, with a follow-up of two years. Subsequently, it will take at least 3 months for data analysis, another 2 months for the final report and at least 3 more months for the publication of the results for publication. This implies that the total duration of the study will be 55 months counted from the inclusion of the first patient.
The procedure will be carried out according to the usual practice of each center, paying special attention to the correct expansion of the scaffold, postdilating with non-compliant balloons when necessary.
The collection of information from the study will be carried out on a data collection template in electronic format, which will include clinical, anatomical, procedural and follow-up data; in baseline circumstances, during hospitalization, after discharge and throughout follow-up at 1, 12, and 24 months. The source documents will be the patient's medical records collected at the center.
The monitoring will be done monthly and online. Two face-to-face monitoring will be done to 20% of the patients, during the inclusion and follow-up phases. Afterwards, a face-to-face monitoring will be carried out for the closing visit.
Descriptive and univariate statistics will be performed. The primary variable is the MACE rate at 12 months, composed of cardiac death, myocardial infarction and TLR induced by ischemia (primary objectives). The secondary variables will be combined indices of events both in the hospital phase, and after discharge in the follow-up at 1, 12 and 24 months.
A final report will be prepared containing all the results of the study, in a period of 6 months once the same one finalized. The participating researchers and the Ethical Committees of the hospitals will be informed about this.
- Conditions
- Coronary Artery Disease
- Being tested
- Magmaris
- Keywords
- Magmaris
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagmarisDevice
Also called Bioresorbable scaffold
Severe stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
A combined rate (incidence of events) of:
The cardiac death (incidence of events).
Measured: 12 months
A combined rate (incidence of events) of:
Myocardial infarction (incidence of events)
Measured: 12 months
A combined rate (incidence of events) of:
Revascularization of the treated lesion (TLR) induced by ischemia (incidence of events)
Measured: 12 months
Secondary outcomes (14)
The event rate will be calculated for:
Cardiovascular deaths
Measured: 24 months
The event rate will be calculated for:
Non-cardiovascular deaths
Measured: 24 months
The event rate will be calculated for:
Myocardial infarctions (MI: QMI and NQMI, TV, NTV)
Measured: 24 months
The event rate will be calculated for:
Revascularization of the treated lesions induced by ischemia (ID-TLR)
Measured: 24 months
The event rate will be calculated for:
Revascularization of the treated vessels induced by ischemia (ID-TVR)
Measured: 24 months
The event rate will be calculated for:
All revascularizations (PCI vs. CABG)
Measured: 24 months
The event rate will be calculated for:
Thrombosis of the device. Classification (acute, sub-acute, delayed) and evidence classification (definitive, probable, possible)
Measured: 24 months
The event rate will be calculated for:
Overlapping devices and features
Measured: 24 months
The event rate will be calculated for:
The immediate success of the device
Measured: 24 months
The event rate will be calculated for:
The immediate success if the procedure
Measured: 24 months
The event rate will be calculated for:
The failure of the lesion treated through a combined rate of cardiac death, TV-IM and ID-TLR: (Failure of treated lesion (TLF))
Measured: 24 months
The event rate will be calculated for:
The failure of the vessel treated through a combined rate of cardiac death, total myocardial infarction and ID-TVR: (Failure of treated vessel (TVF))
Measured: 24 months
The rate of:
Overlapping stents will be calculated in relation to those implanted, and the relation with the appearance of clinical events.
Measured: 24 months
The rate of:
Image parameters will be calculated in the cases in which, in the opinion of the researcher, coronary function or intravascular imaging tests have been performed (FFR, IVUS, OCT).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start26 Jul 2017
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Iñiguez Romo, MD, Spanish Society of Cardiology
- Investigators
- Andres I Romo, MD, PhD, Study director, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413813
- Sponsor's protocol ID
- MAGMARIS-ES
- Acronym
- MAGMARIS
- Status last verified
- Jul 2021
- First submitted
- 21 Dec 2017
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Registry of Patients With a Bioabsorbable Magnesium Stent Implant -MAGMARIS- in Usual Clinical Practice
- ClinicalTrials.gov ID
- NCT03413813
- Acronym / sponsor ID
- MAGMARIS / MAGMARIS-ES
- Conditions
- Coronary Artery Disease
- Keywords
- Magmaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of percutaneous coronary revascularization has been progressively increasing since its inception, and the problem of restenosis has been minimized.
The efficacy and safety data of the Magmaris stent are quite high, in selected cases.
The objective is to evaluate the efficacy and safety of the bioabsorbable stent MAGMARIS in the percutaneous treatment of severe coronary disease (in vessels between 2.7mm and 3.75 mm) in routine clinical practice in poorly selected populations.
Detailed description
This is a multicentre, observational, prospective registry of patients without a control group designed to evaluate the efficacy and safety of the bioabsorbable coronary device, according to the indications for use, in routine clinical practice in a consecutive number of patients undergoing percutaneous coronary intervention (PCI) in de novo coronary arteries lesions in a native coronary artery.
After the implantation of the device, a telephone or face-to-face follow-up will be carried out in the first month, at 12 months and at 24 months.
A total of 445 patients are expected to be included in the registry. Patients, will be included consecutively in each center over a year. A selection period of 23 months or until the estimated sample size has been planned, with a follow-up of two years. Subsequently, it will take at least 3 months for data analysis, another 2 months for the final report and at least 3 more months for the publication of the results for publication. This implies that the total duration of the study will be 55 months counted from the inclusion of the first patient.
The procedure will be carried out according to the usual practice of each center, paying special attention to the correct expansion of the scaffold, postdilating with non-compliant balloons when necessary.
The collection of information from the study will be carried out on a data collection template in electronic format, which will include clinical, anatomical, procedural and follow-up data; in baseline circumstances, during hospitalization, after discharge and throughout follow-up at 1, 12, and 24 months. The source documents will be the patient's medical records collected at the center.
The monitoring will be done monthly and online. Two face-to-face monitoring will be done to 20% of the patients, during the inclusion and follow-up phases. Afterwards, a face-to-face monitoring will be carried out for the closing visit.
Descriptive and univariate statistics will be performed. The primary variable is the MACE rate at 12 months, composed of cardiac death, myocardial infarction and TLR induced by ischemia (primary objectives). The secondary variables will be combined indices of events both in the hospital phase, and after discharge in the follow-up at 1, 12 and 24 months.
A final report will be prepared containing all the results of the study, in a period of 6 months once the same one finalized. The participating researchers and the Ethical Committees of the hospitals will be informed about this.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease by de novo lesions in native coronary arteries, candidates for revascularization with coronary stent.
Key inclusion criteria (14 listed)
- BASIC CRITERIA:
- CLINICAL CRITERIA:
- ANGIOGRAPHICAL CRITERIA:
Key exclusion criteria (14 listed)
- CLINICS:
- ANATOMICS:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagmarisAlso: Bioresorbable scaffoldSevere stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation. | Device | – |
Primary outcome
A combined rate (incidence of events) of:
Time frame: 12 months
The cardiac death (incidence of events).
A combined rate (incidence of events) of:
Time frame: 12 months
Myocardial infarction (incidence of events)
A combined rate (incidence of events) of:
Time frame: 12 months
Revascularization of the treated lesion (TLR) induced by ischemia (incidence of events)
14 secondary outcomes
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The event rate will be calculated for:
Time frame: 24 months
The rate of:
Time frame: 24 months
The rate of:
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres I Romo, MD, PhD study director
Spanish Society of Cardiology
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Spanish Society of Cardiology at 31 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A combined rate (incidence of events) of: (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.